ATOM is the only active Phase 3 trial for
adjuvant treatment of uveal melanoma
The trial will assess whether adjuvant treatment
with tebentafusp can decrease the risk of relapse, compared to
observation
(OXFORDSHIRE, England & CONSHOHOCKEN, Penn.
& ROCKVILLE, Md., US, 11 December 2024) The European
Organisation for Research and Treatment of Cancer (EORTC), an
independent clinical cancer research organization focusing on
improving the standards of cancer treatments for patients to
prolong survival and improve quality of life, and Immunocore
Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a
commercial-stage biotechnology company pioneering and delivering
transformative immunomodulating medicines to radically improve
outcomes for patients with cancer, infectious diseases and
autoimmune diseases, today announce the randomization of the first
patient in the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM),
investigating the safety and efficacy of tebentafusp as adjuvant
treatment for uveal melanoma.
The primary objective of the open-label,
international, multicenter trial – led by EORTC – will be to assess
whether tebentafusp can prevent or delay relapse in patients with
primary ocular (uveal) melanoma at high risk of relapse, as
compared with observation. Tebentafusp is approved for the
treatment of HLA-A*02:01-positive adult patients with unresectable
or metastatic uveal melanoma in 38 countries, under the brand name
KIMMTRAK®.
“I am delighted that the first patient on ATOM
has been recruited. This milestone reflects a very significant
effort by the EORTC melanoma group trials team, colleagues at
Immunocore and our trial sites,” said Professor Paul Nathan, ATOM
study coordinator. “The study addresses a key question - whether
the benefit seen with tebentafusp in HLA-A*02:01-positive patients
with metastatic uveal melanoma will translate to a significant
reduction in risk of relapse for patients who have received
treatment for primary uveal melanoma and are at high risk of
relapse.”
The trial is expected to enroll 290
HLA-A*02:01-positive patients with uveal melanoma who have
undergone definitive treatment by surgery or radiotherapy. Eligible
patients will be randomized 1:1 to one of two arms: tebentafusp [as
monotherapy] for six months or until disease relapse, or
observation. Secondary objectives include overall survival, safety
and tolerability, while exploratory objectives include evaluation
of circulating tumor DNA (ctDNA) as a marker of residual disease,
and a comparison of health-related quality of life.
Mohammed Dar, Chief Medical Officer at
Immunocore, said: “Despite definitive local therapy, approximately
50% of patients will eventually relapse with metastatic disease.
The goal of investigating adjuvant tebentafusp following primary
treatment is to prevent future recurrence. Decreasing the
likelihood of a patient relapsing following definitive therapy for
their primary disease would be a groundbreaking advancement in
treatment, given there are currently no standard treatment options
available in this setting.”
###
About the ATOM Phase 3
trial
ATOM (NCT06246149; 2023-510333-28-00) is an
EORTC-led randomized open-label international multicenter Phase 3
superiority clinical trial aiming to prospectively assess whether
adjuvant treatment with tebentafusp improves relapse-free survival
as compared with observation. A total of 290 patients are expected
to be enrolled within a span of three years, beginning in 13
countries, and with the potential for further expansion.
The goal of the experimental treatment strategy
in the trial is to establish whether adjuvant tebentafusp can
decrease the risk of relapse – compared to observation – in
patients who have undergone definitive treatment for primary uveal
melanoma and who are at high risk of relapse.
Patients included in the study must have
undergone definitive treatment for primary ocular melanoma, by
surgery or radiotherapy; be at high risk of relapse; be HLA-A*02:01
positive; have a good performance status (ECOG 0/1); and adequate
organ function. Eligible patients will be randomized 1:1 to receive
either active treatment with weekly tebentafusp [as monotherapy],
or observation. Patients will receive tebentafusp for 6 months, or
until relapse.
The secondary objectives are to compare overall
survival and to further document the safety and tolerability of
tebentafusp.
The exploratory objectives include the
comparison of the health-related quality of life between the
treatment arms and the evaluation of the role of circulating tumor
DNA (ctDNA) as a biomarker for the presence of residual
disease.
About Uveal Melanoma
Uveal melanoma is a rare disease arising from
the pigmented uveal tract of the eye with an estimated incidence in
Europe of 4.4 cases per million1. Up to 50% of people with uveal
melanoma will eventually develop metastatic disease2. Metastases
usually appear within a median of three to five years after
treatment of primary tumors, and treatment of metastatic disease is
usually with palliative intent. Unresectable or metastatic uveal
melanoma typically has a poor prognosis and had no approved
treatment until KIMMTRAK.
Very few studies have tested the use of adjuvant
treatment in uveal melanoma, and none have resulted in any change
in the standard of care, reflecting a lack of active agents for
this disease.
About ImmTAC®
molecules for cancer
Immunocore’s proprietary T cell receptor (TCR)
technology generates a novel class of bispecific biologics called
ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules
that are designed to redirect the immune system to recognize and
kill cancerous cells. ImmTAC molecules are soluble TCRs engineered
to recognize intracellular cancer antigens with ultra-high affinity
and selectively kill these cancer cells via an anti-CD3
immune-activating effector function. Based on the demonstrated
mechanism of T cell infiltration into human tumors, the ImmTAC
mechanism of action holds the potential to treat hematologic and
solid tumors, regardless of mutational burden or immune
infiltration, including immune “cold” low mutation rate tumors.
About EORTC
The European Organisation for Research and
Treatment of Cancer (EORTC) is an academic clinical research
organisation, which unites clinical cancer research experts across
the globe to define better treatments for cancer patients to
prolong survival and improve quality of life. Both international
and multidisciplinary, EORTC’s network comprises over 3400
collaborators involved in cancer treatment and research in 917
institutions across 50 countries. Conducting translational
research, and phase 2 and 3 trials, EORTC offers an integrated
approach to therapeutic strategies and quality of life. EORTC
Headquarters, a unique international clinical research
infrastructure, are based in Brussels, Belgium, from where its
various activities are coordinated and run. For further
information, please visit the EORTC website: www.eortc.org
About Immunocore
Immunocore is a commercial-stage biotechnology
company pioneering the development of a novel class of TCR
bispecific immunotherapies called ImmTAX – Immune mobilizing
monoclonal TCRs Against X disease – designed to treat a broad range
of diseases, including cancer, autoimmune, and infectious disease.
Leveraging its proprietary, flexible, off-the-shelf ImmTAX
platform, Immunocore is developing a deep pipeline in multiple
therapeutic areas, including nine active clinical and pre-clinical
programs in oncology, infectious diseases, and autoimmune diseases.
The Company’s most advanced oncology TCR therapeutic, KIMMTRAK has
been approved for the treatment of HLA-A*02:01-positive adult
patients with unresectable or metastatic uveal melanoma in the
United States, European Union, Canada, Australia, and the United
Kingdom.
Immunocore Forward Looking
Statements
This press release contains “forward-looking
statements” within the meaning of the safe harbor provisions of the
Private Securities Litigation Reform Act of 1995. Words such as
“may,” “will,” “believe,” “expect,” “plan,” “anticipate,”
“estimate,” and similar expressions (as well as other words or
expressions referencing future events or circumstances) are
intended to identify forward-looking statements. All statements,
other than statements of historical facts, included in this press
release are forward-looking statements. These statements include,
but are not limited to, statements regarding the marketing and
therapeutic potential of KIMMTRAK for mUM; the expected clinical
benefits of KIMMTRAK and the Company’s other product candidates,
including the prevention or delay of relapse for patients with
primary uveal melanoma; the value proposition of Immunocore’s
product candidates, including KIMMTRAK, including expectations
regarding the potential patient population and market opportunity;
future development plans of KIMMTRAK; and expectations regarding
the design, progress, timing, scope and results of Immunocore’s
existing and planned clinical trials, including the ATOM trial and
its potential for further expansion. Any forward-looking statements
are based on management’s current expectations and beliefs of
future events and are subject to a number of risks and
uncertainties that could cause actual events or results to differ
materially and adversely from those set forth in or implied by such
forward-looking statements, many of which are beyond the Company’s
control. These risks and uncertainties include, but are not limited
to, the impact of worsening macroeconomic conditions on the
Company’s business, financial position, strategy and anticipated
milestones, including Immunocore’s ability to conduct ongoing and
planned clinical trials; Immunocore’s ability to obtain a clinical
supply of current or future product candidates or commercial supply
of KIMMTRAK or any future approved products, including as a result
of health epidemics or pandemics, war in Ukraine, the conflict in
the Middle East, or global geopolitical tension; Immunocore’s
ability to obtain and maintain regulatory approval of its product
candidates, including KIMMTRAK; Immunocore’s ability and plans in
continuing to establish and expand a commercial infrastructure and
to successfully launch, market and sell KIMMTRAK and any future
approved products; Immunocore’s ability to successfully expand the
approved indications for KIMMTRAK or obtain marketing approval for
KIMMTRAK in additional geographies in the future; the delay of any
current or planned clinical trials, whether due to patient
enrolment delays or otherwise; Immunocore’s ability to successfully
demonstrate the safety and efficacy of its product candidates and
gain approval of its product candidates on a timely basis, if at
all; competition with respect to market opportunities; unexpected
safety or efficacy data observed during preclinical studies or
clinical trials; actions of regulatory agencies, which may affect
the initiation, timing and progress of clinical trials or future
regulatory approval; Immunocore’s need for and ability to obtain
additional funding, on favourable terms or at all, including as a
result of worsening macroeconomic conditions, including inflation,
interest rates and unfavourable general market conditions, and the
impacts thereon of the war in Ukraine, conflict in the Middle East,
and global geopolitical tension; Immunocore’s ability to obtain,
maintain and enforce intellectual property protection for KIMMTRAK
or any of its product candidates it or its collaborators are
developing; and the success of Immunocore’s current and future
collaborations, partnerships or licensing arrangements. These and
other risks and uncertainties are described in greater detail in
the section titled "Risk Factors" in Immunocore’s filings with the
Securities and Exchange Commission, including Immunocore’s most
recent Annual Report on Form 10-K for the year ended December 31,
2023 filed with the Securities and Exchange Commission on February
28, 2024, as well as discussions of potential risks, uncertainties,
and other important factors in the Company’s subsequent filings
with the Securities and Exchange Commission. All information in
this press release is as of the date of the release, and the
Company undertakes no duty to update this information, except as
required by law.
Contact Information
EORTC Communications
Caroline Moulins, Head of CommunicationsT: +32 2
774 13 68E: caroline.moulins@eortc.org
Immunocore Corporate
Communications
Sébastien Desprez, Head of CommunicationsT: +44
(0) 7458030732E: sebastien.desprez@immunocore.com
Immunocore Investor
Relations
Clayton Robertson, Head of Investor RelationsT:
+1 (215) 384-4781E: ir@immunocore.com
1 Virgili G, Gatta G, Ciccolallo L, Capocaccia R,
Biggeri A, Crocetti E, et al. Incidence of Uveal Melanoma in
Europe. Ophthalmology 2007.
https://doi.org/10.1016/j.ophtha.2007.01.032.2 Shields CL, Furuta
M, Thangappan A, Nagori S, Mashayekhi A, Lally DR, et al.
Metastasis of uveal melanoma millimeter-by-millimeter in 8033
consecutive eyes. Arch Ophthalmol 2009.
https://doi.org/10.1001/archophthalmol.2009.208.
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